Alternative Methods to Animal Tests
To ensure the high quality and safety of human and veterinary medicines, the current state of science and technology does not always allow avoiding animal tests for such medicines. The European Pharmacopoeia requires these animal experiments as mandatory tests.
The Paul-Ehrlich-Institut (PEI) is committed to minimising the use of animals in medicine testing and to avoiding pain and distress wherever possible, without sacrificing the quality, efficacy and safety of medicines. These alternative methods to animal experiments follow the 3R concept (Replacement, Reduction, Refinement) (Russel and Burch, 1959). They include testing procedures that allow either
- to completely replace animal experiments (replacement) or, if this is not possible,
- to reduce the number of animals used (reduction) or
- to reduce the level of suffering of the animals (refinement).
The PEI continuously develops alternative methods, the use of which makes an animal experiment unnecessary or significantly reduces the number of laboratory animals or their sufffering. Some of the methods newly developed at the PEI have contributed to changes in legislation. Wherever possible, the 3R methods should be used in medicine testing. This has been taken into account in the provisions of the European Convention for the Protection of Vertebrate Animals used for experimental and other scientific purposes, 1986 and in Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. The official German edition of the pharmacopoeia, the national supplement to the European Pharmacopoeia, also points to this in several places.
Waiver of Fees
In addition to the ethical aspect, there is also a concrete financial incentive for the pharmaceutical entrepreneur to introduce animal experiment replacement methods. Pursuant to Section 4 (8) of the Statutory CostsRegulation for Official Duties of the PEI pursuant to the German Medicines Act (PEI-KostVO) and Section 3 of the Statutory Cost Regulation relating to vaccines for veterinary use (Tierimpfstoff-Kostenverordnung), the fee for amending the test method for an approved medicinal product can be reduced or completely waived, if this change results in the replacement or prevention of animal testing.